Meta-analysis Supports CGRP-Targeted Drugs for Episodic Migraine

By Annette M. Boyle, /alert Contributor
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In the last two years, the U.S. Food and Drug Administration has approved four drugs that target calcitonin gene-related peptide (CGRP) for use in migraine prevention. A recent meta-analysis looked at the new class of drugs’ efficacy and safety for episodic migraine across 11 studies and found significant benefit.

The studies were all multi-center, randomized, double-blind, placebo-controlled trials of the approved CGRP-targeting monoclonal antibodies: erenumab, eptinezumab, fremanezumab, and galcanezumab. Six were phase 2 trials and 5 were phase 3 trials.

Combined, the studies enrolled 4,402 adult patients with episodic migraines. All 11 trials found that the CGRP-antagonists reduced the average number of monthly migraine days compared to placebo, with a pooled weighted mean difference of 1.44 days.

All 11 studies determined that the CGRP multiclonal antibodies had a higher rate of 50% responders compared to placebo on an individual basis. On a pooled basis, the CGRP antagonists had a RR of 1.51 compared to placebo. 

Eight trials reported changes in days of acute migraine-specific medications per month. Those trials evaluated just three of the drugs: erenumab, fremanezumab, and galcanezumab. On both an individual and pooled bases, the studies demonstrated a significant reduction in migraine-specific medication days for the drugs compared to placebo. The weighted mean difference showed a decline of 1.28 days in the pooled analysis.

Adverse event data signaled excellent safety profiles for the class. On both a pooled and subgroup basis, the studies demonstrated that each CGRP multiclonal antibody had no significantly greater risk than placebo. The only adverse event that had higher rates in any of the drugs compared to placebo was injection site pain.

Another recent study presented at the 2020 American Academy of Neurology Science Highlights examined real world reports of adverse events for the first three approved drugs in the class. It found that in the first six months post approval, cardiovascular events did not rank in the top 10 adverse events for erenumab, fremanezumab or galcanezumab. Injection site pain was common in all three, as were headache/migraine, drug ineffective, and nausea.

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